This study investigated whether adding a three-dimensional (3D) imaging view during colonoscopy helps doctors classify small colon polyps more accurately than standard colonoscopy without 3D. Polyps are small growths in the colon that may develop into cancer over time. When doctors remove polyps, they often examine them closely during the procedure to judge how likely they are to be precancerous-a process called optical diagnosis. In this study, two approaches to optical diagnosis were compared: diagnosis using standard colonoscopy without 3D, and diagnosis using the same colonoscopy with additional 3D imaging. Both groups used the same classification systems (JNET and WASP) to identify polyp type; the only difference was whether 3D imaging was used. The main question was whether adding 3D improves the agreement between the doctor's diagnosis during colonoscopy and the final laboratory diagnosis of the removed polyp. The study also collected safety information. Participants were randomly assigned to one of the two groups, like flipping a coin. Regardless of group, all participants underwent an initial colonoscopy to detect polyps, a second colonoscopy to remove polyps and perform optical diagnosis, and a follow-up period of up to 30 days to monitor for side effects. The study included adults with at least one colon polyp smaller than 10 mm that did not require a more advanced type of removal called ESD.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
SINGLE
Enrollment
458
Real-time optical diagnosis of colorectal polyps \<10 mm before polypectomy, based on the JNET classification with additional WASP features for JNET Type 1 lesions, using standard high-definition colonoscopy without 3D assistance.
Real-time optical diagnosis of colorectal polyps \<10 mm before polypectomy, based on the JNET classification with additional WASP features for JNET Type 1 lesions, using standard high-definition colonoscopy with 3D imaging assistance.
Xijing Hospital of Digestive Disease
Xi'an, Shaanxi, China
Overall diagnostic concordance of endoscopic polyp classification
The overall proportion of correct classifications by endoscopy (3D vs. non-3D) compared to the gold standard (pathology) at the lesion level, across all polyp types.
Time frame: 1-7 days after polypectomy
Diagnostic confidence
The proportion of lesions classified with high versus low diagnostic confidence by the endoscopist during real-time optical diagnosis. High confidence was defined as clear visualization of both vascular and surface patterns permitting a definitive JNET classification; low confidence was defined as suboptimal visualization or ambiguous features precluding a definitive classification.
Time frame: During the endoscopic procedure, immediately after optical diagnosis
Diagnostic concordance for adenomas and sessile serrated lesions (SSLs)
The overall proportion of correct classifications by endoscopy compared with the gold standard (pathology) at the lesion level for adenomas and for sessile serrated lesions, respectively.
Time frame: 1-7 days after polypectomy
Diagnostic concordance for identifying patients requiring surveillance
The proportion of patients for whom the surveillance interval assigned by optical diagnosis matches the interval assigned by pathology, according to the 2020 ESGE guideline. Surveillance intervals were determined based on all resected polyps, including those \>10 mm, reflecting real-world clinical practice.
Time frame: 1-7 days after polypectomy
Diagnostic characteristics (sensitivity, specificity, PPV, NPV) for adenomas and SSLs
Diagnostic performance measures for endoscopic classification (3D vs. non-3D) in detecting adenomas and sessile serrated lesions at the lesion level, using final pathology as the gold standard. Measures include sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV).
Time frame: 1-7 days after polypectomy
The colonoscopy-relevant adverse events
aspiration pneumonia, perforation, bleeding, splenic injury/rupture, death, or others requiring hospitalization within 30 days after the colonoscopy
Time frame: 1-30 days after polypectomy
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